Respiratory Syncytial Virus Lower Respiratory Tract InfectionPhase 2NCT03468829
Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection
A Phase 2 study testing ALX-0171 Dose 1 and ALX-0171 Dose 2 in people with Respiratory Syncytial Virus Lower Respiratory Tract Infection, run by Ablynx, a Sanofi company at 5 sites in 3 countries.
Trial summary
The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory Syncytial Virus Lower Respiratory Tract Infection
- What is being tested?
- ALX-0171 Dose 1 and ALX-0171 Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Feb 2019to May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has received an HSCT using any conditioning regimen and for any underlying etiology (i.e., subject has received an autologous or allogeneic HSCT)
- Subject is clinically diagnosed with RSV infection with new onset or acute worsening
- Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization.
- Documented RSV infection in the upper respiratory tract (URT)
- Subject has:
- Diagnosis of RSV lower respiratory tract (LRT) disease or
- Diagnosis of RSV URT disease with high risk of progression to lower respiratory tract infection (LRTI)
- Others as defined in the protocol
Who cannot join
- Subject has clinically significant bacteremia or fungemia within 7 days of screening
- Subject has clinically significant bacterial, fungal or viral pneumonia
- Subject presents evidence of shock requiring intensive care unit (ICU) monitoring and/or vasopressor treatment
- Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support. Standard oxygen supplementation up to 6 L/minute is permitted provided it can be interrupted for the duration of study drug administration.
- Others as defined in the protocol
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
Official title: A Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of ALX 0171 Versus Placebo, in Addition to Standard of Care, in Adults Who Have Undergone Hematopoietic Stem Cell Transplantation and Present With a Respiratory Syncytial Virus Respiratory Tract Infection
The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell transplantation (HSCT).
The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology, and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract infection after HSCT.
- Being tested
- ALX-0171 Dose 1, ALX-0171 Dose 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX-0171 Dose 1Biological
Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
ALX-0171 Dose 2Biological
Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days
PlaceboBiological
Oral inhalation of Placebo once daily for a maximum of 14 days
| Study group | Role | What they receive |
|---|---|---|
| ALX-0171 Dose 1 | Experimental | Not described Receives: Biological: ALX-0171 Dose 1 |
| ALX-0171 Dose 2 | Experimental | Not described Receives: Biological: ALX-0171 Dose 2 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average change from baseline in log10 RSV nasal viral load
Measured: From Day 1 to Day 7
Secondary outcomes (7)
Safety as measured by the incidence of treatment-emergent (serious) adverse events
Measured: From Screening to Day 42
Nasal RSV load parameter: time to undetectable shedding
Measured: From Day 1 to Day 42
Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours)
Measured: From Day 1 to Day 42
Number of days without oxygen or with oxygen supplementation
Measured: From Day 1 to Day 42
Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline
Measured: From Day 1 to Day 42
Concentration of ALX-0171 in serum
Measurement of ALX-0171 serum concentration at different time points from baseline until Day 14.
Measured: Day 1 to Day 14
Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum
Measured: From Day 1 to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study startFeb 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: ALX-0171 development program was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus Lower Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ablynx Clinical Department, Study director, Ablynx, a Sanofi company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468829
- Sponsor's protocol ID
- ALX0171-C204
- Other IDs
- 2017-003356-23, 2017
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2018
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of ALX 0171 Versus Placebo, in Addition to Standard of Care, in Adults Who Have Undergone Hematopoietic Stem Cell Transplantation and Present With a Respiratory Syncytial Virus Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT03468829
- Acronym / sponsor ID
- ALX0171-C204
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: ALX-0171 development program was stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Feb 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell transplantation (HSCT).
The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology, and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract infection after HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALX-0171 Dose 1 | Experimental | Biological: ALX-0171 Dose 1 |
| ALX-0171 Dose 2 | Experimental | Biological: ALX-0171 Dose 2 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has received an HSCT using any conditioning regimen and for any underlying etiology (i.e., subject has received an autologous or allogeneic HSCT)
- Subject is clinically diagnosed with RSV infection with new onset or acute worsening
- Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization.
- Documented RSV infection in the upper respiratory tract (URT)
- Subject has:
Key exclusion criteria (5 listed)
- Subject has clinically significant bacteremia or fungemia within 7 days of screening
- Subject has clinically significant bacterial, fungal or viral pneumonia
- Subject presents evidence of shock requiring intensive care unit (ICU) monitoring and/or vasopressor treatment
- Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support. Standard oxygen supplementation up to 6 L/minute is permitted provided it can be interrupted for the duration of study drug administration.
- Others as defined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALX-0171 Dose 1Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days | Biological | ALX-0171 Dose 1 |
| ALX-0171 Dose 2Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days | Biological | ALX-0171 Dose 2 |
| PlaceboOral inhalation of Placebo once daily for a maximum of 14 days | Biological | Placebo |
Primary outcome
Time-weighted average change from baseline in log10 RSV nasal viral load
Time frame: From Day 1 to Day 7
7 secondary outcomes
Safety as measured by the incidence of treatment-emergent (serious) adverse events
Time frame: From Screening to Day 42
Nasal RSV load parameter: time to undetectable shedding
Time frame: From Day 1 to Day 42
Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours)
Time frame: From Day 1 to Day 42
Number of days without oxygen or with oxygen supplementation
Time frame: From Day 1 to Day 42
Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline
Time frame: From Day 1 to Day 42
Concentration of ALX-0171 in serum
Time frame: Day 1 to Day 14
Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum
Time frame: From Day 1 to Day 42
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ablynx Clinical Department study director
Ablynx, a Sanofi company
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALX-0171 Dose 1 and ALX-0171 Dose 2 in people with Respiratory Syncytial Virus Lower Respiratory Tract Infection, run by Ablynx, a Sanofi company at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average change from baseline in log10 RSV nasal viral load (time frame: From Day 1 to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.